Drug Enforcement Administration February 2016 – Federal Register Recent Federal Regulation Documents

Removal of Exemption From Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan
Document Number: 2016-04224
Type: Rule
Date: 2016-02-26
Agency: Drug Enforcement Administration, Department of Justice
On November 25, 2014, the Drug Enforcement Administration published the interim final rule titled ``Exemption from Registration for Persons Authorized Under U.S. Nuclear Regulatory Commission or Agreement State Medical Use Licenses or Permits and Administering the Drug Product DaTscan.'' The Drug Enforcement Administration is hereby removing this interim final rule as it is no longer needed, as a result of the removal of [\123\I]ioflupane from the schedules of controlled substances effective September 11, 2015.
Manufacturer of Controlled Substances Registration: Chemtos, LLC
Document Number: 2016-03856
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Chemtos, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Chemtos, LLC registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Insys Therapeutics, Inc.
Document Number: 2016-03855
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA).
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2016-03854
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc.
Document Number: 2016-03853
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Cedarburg Pharmaceuticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of those controlled substances.
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
Document Number: 2016-03852
Type: Notice
Date: 2016-02-24
Agency: Drug Enforcement Administration, Department of Justice
Arvinder Singh, M.D.; Decision and Order
Document Number: 2016-03361
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural History
Document Number: 2016-03359
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC
Document Number: 2016-03358
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance.
Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC
Document Number: 2016-03357
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Mallinckrodt, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC registration as a manufacturer of those controlled substances.
Manufacturer of Controlled Substances Registration: Euticals, Inc.
Document Number: 2016-03355
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances.
Importer of Controlled Substances Registration: Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC
Document Number: 2016-03353
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC applied to be registered as an importer of a basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC registration as an importer of this controlled substance.
Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc.
Document Number: 2016-03350
Type: Notice
Date: 2016-02-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-02863
Type: Notice
Date: 2016-02-12
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA in Schedule I of the Controlled Substances Act
Document Number: 2016-02308
Type: Rule
Date: 2016-02-05
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order to extend the temporary schedule I status of four synthetic cannabinoids pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB- 22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)- 1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), including their optical, positional and geometric isomers, salts, and salts of isomers. The current final order temporarily placing PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA into schedule I is in effect through February 9, 2016. This final order will extend the temporary scheduling of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA for one year, or until the permanent scheduling action for these four substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA into Schedule I
Document Number: 2016-02305
Type: Proposed Rule
Date: 2016-02-05
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing quinolin- 8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1- (5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N- (1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-inda zole-3- carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This proposed scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle PB- 22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.
Schedules of Controlled Substances: Temporary Placement of the Synthetic Cannabinoid MAB-CHMINACA Into Schedule I
Document Number: 2016-02302
Type: Rule
Date: 2016-02-05
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic cannabinoid N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- (cyclohexylmethyl)-1H-indazole-3-carboxamide (common names, MAB- CHMINACA and ADB-CHMINACA), and its optical, positional, and geometric isomers, salts, and salts of isomers into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this synthetic cannabinoid into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, MAB-CHMINACA.
Louis Watson, M.D.; Decision and Order
Document Number: 2016-02130
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
Kenneth H. Bull, M.D.; Decision and Order
Document Number: 2016-02129
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc.
Document Number: 2016-02128
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice
David W. Bailey, M.D.; Decision and Order
Document Number: 2016-02127
Type: Notice
Date: 2016-02-04
Agency: Drug Enforcement Administration, Department of Justice